Overweight , ObesityACTIONNCT07922005
Lifestyle Interventions and Genetic Scores for Weight Management
A study testing Structured Jogging Program, Habitual Physical Activity Recommendations and Structured Yoga Program in people with Overweight , Obesity, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
The ACTION (Genotype-tAilored exerCise inTerventION) study investigated whether genetic information related to obesity susceptibility and endurance capacity could be used to inform personalized lifestyle interventions aimed at improving body mass index (BMI) and participation in physical activity programs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight , Obesity
- What is being tested?
- Structured Jogging Program, Habitual Physical Activity Recommendations and Structured Yoga Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteGreece
- Study dates
- 29 Oct 2023to 22 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Greek residents who had previously undergone genome-wide genotyping and baseline anthropometric and lifestyle assessment.
- Elevated genetic susceptibility to obesity, defined by the High or Max BMI Genetic Risk Score (BMI-GRS) categories.
- Low habitual physical activity at baseline.
- Voluntary agreement to participate in an eight-week lifestyle intervention.
- Enrollment was prioritized for individuals with BMI-GRS values above the 70th percentile when the number of eligible volunteers exceeded the available intervention capacity.
Who cannot join
- Missing anthropometric measurements or essential baseline covariate data.
- Body-weight change greater than 3% during the preceding three months.
- Previous bariatric surgery.
- Untreated psychiatric disorders.
- Use of medications known to influence body weight.
- For the initial intervention cohort, habitual participation in jogging at baseline.
Trial locations and contacts
1 site in 1 country.
Greece1 site
National and Kapodistrian University of Athens, School of Medicine
Athens, Attica, 11527
About this study
Official title: Lifestyle Interventions and Genetic Susceptibility in Body Mass Index Management: The ACTION Study
The ACTION (Genotype-tAilored exerCise inTerventION) study investigated whether genetic information related to obesity susceptibility and endurance capacity could be used to inform personalized lifestyle interventions aimed at improving body mass index (BMI) and participation in physical activity programs.
Adults with increased genetic susceptibility to obesity and low habitual physical activity were invited to participate in an eight-week lifestyle intervention combining dietary counseling with physical activity recommendations.
Read more
The intervention initially compared structured jogging with recommendations to increase habitual physical activity. Following the evaluation of intervention completion, the exercise strategy was modified for a subsequent group of participants, incorporating a Genetic Endurance Score (GES) to guide allocation to jogging or yoga.
The study evaluated changes in BMI and completion of the assigned exercise programs, exploring the feasibility of integrating genetic information into personalized lifestyle recommendations.
Read the detailed description
The ACTION (Genotype-tAilored exerCise inTerventION) study was designed to investigate the potential of integrating polygenic susceptibility to obesity and genetically predicted endurance capacity into lifestyle interventions for BMI management.
The study included an observational analysis of 918 genotyped Greek adults recruited during two consecutive study periods. A weighted BMI Genetic Risk Score (BMI-GRS), based on 97 genetic variants, was used to assess obesity susceptibility, while habitual physical activity was assessed using the International Physical Activity Questionnaire (IPAQ-Gr).
Adults with increased obesity-related genetic susceptibility were invited to participate in the intervention component. Enrollment was prioritized for individuals with BMI-GRS values above the 70th percentile and low habitual physical activity. A total of 198 participants were enrolled in eight-week lifestyle interventions across two sequential cohorts.
All intervention participants received a common genetic risk-adapted dietary program and individualized lifestyle counseling. Dietary recommendations emphasized healthy eating habits, reduced saturated fat and refined carbohydrate intake, increased dietary fiber and plant-based food consumption, and regular fish consumption.
In the initial intervention cohort (n=113), participants were systematically allocated according to enrollment order to structured jogging (n=77) or recommendations to increase habitual physical activity (n=36). The primary objective was to evaluate changes in BMI following eight weeks of intervention.
Following discontinuation of the initial intervention, exploratory analyses investigated the association between genetically predicted endurance capacity and exercise program completion. These observations motivated a modification of the intervention strategy.
In the subsequent cohort (n=85), exercise allocation was guided by a nine-variant Genetic Endurance Score (GES). Participants with GES ≥50 were assigned to structured jogging (n=35), while those with GES <50 were assigned to structured yoga (n=50). This phase assessed eight-week intervention completion and short-term BMI change.
BMI was calculated from measured weight and height. Intervention completion was defined by completion of the assigned eight-week program and attendance at the final assessment. Discontinuation of the intervention was recorded.
Comparisons between the sequential intervention cohorts were considered exploratory because the cohorts were recruited at different times and exercise allocation procedures differed. The genotype-guided allocation strategy was developed following observations from the initial intervention and was not part of the original intervention design.
- Conditions
- Overweight , Obesity
- Being tested
- Structured Jogging Program, Habitual Physical Activity Recommendations, Structured Yoga Program, Genetic Risk-Adapted Dietary Counseling
- Keywords
- Polygenic Risk Score, Genetic Susceptibility to Obesity, Personalized Lifestyle Intervention, Body Mass Index
- Medical subject headings
- Overweight, Obesity, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Jogging ProgramBehavioural
An eight-week structured jogging program aimed at increasing weekly physical activity relative to baseline. The intervention was implemented in both sequential cohorts: 77 participants in the initial cohort and 35 participants with a Genetic Endurance Score (GES) ≥50 in the subsequent cohort. All participants also received common dietary counseling.
Habitual Physical Activity RecommendationsBehavioural
Participants received individualized recommendations to increase their weekly physical activity through their habitual forms of exercise, without assignment to a structured jogging or yoga program. This eight-week intervention was implemented in the initial cohort (n=36), alongside the common genetic risk-adapted dietary counseling program. Physical activity recommendations aimed to increase weekly activity relative to baseline.
Structured Yoga ProgramBehavioural
An eight-week structured yoga program assigned to participants with a Genetic Endurance Score (GES) below 50. The intervention was implemented in the subsequent cohort (n=50) as an alternative to structured jogging for individuals with lower genetically predicted endurance capacity. All participants also received the common genetic risk-adapted dietary counseling program.
Genetic Risk-Adapted Dietary CounselingBehavioural
All 198 intervention participants received a common eight-week genetic risk-adapted dietary counseling program designed to support gradual weight loss. Recommendations emphasized reducing saturated fat and refined carbohydrate intake, increasing dietary fiber and plant-based foods, regular fish consumption, and behavioral strategies to support dietary adherence. The same dietary protocol was applied in both sequential intervention cohorts.
| Study group | Role | What they receive |
|---|---|---|
| Structured Jogging | Experimental | Participants assigned to structured jogging followed an eight-week exercise program together with common genetic risk-adapted dietary counseling. This arm included 77 participants from the initial cohort, allocated systematically by enrollment order, and 35 participants from the subsequent cohort, allocated according to a Genetic Endurance Score (GES) ≥50. A total of 112 participants received the jogging intervention. Receives: Behavioral: Structured Jogging Program; Behavioral: Genetic Risk-Adapted Dietary Counseling |
| Cohort-Specific Physical Activity | Active comparator | This arm represents the alternative physical activity strategy used in each intervention cohort. In the initial cohort, 36 participants received recommendations to increase physical activity through their habitual activities. In the subsequent cohort, 50 participants with a Genetic Endurance Score (GES) <50 were assigned to structured yoga. Both groups received the common dietary counseling intervention for eight weeks. The two exercise strategies were implemented in separate, sequential cohorts and were not identical interventions. Receives: Behavioral: Habitual Physical Activity Recommendations; Behavioral: Structured Yoga Program; Behavioral: Genetic Risk-Adapted Dietary Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Reduction in Body Mass Index (BMI) From Baseline to Week 8
Percentage BMI reduction was calculated as 100 × (baseline BMI - BMI at week 8) / baseline BMI, with positive values indicating a reduction in BMI. BMI was calculated from measured body weight (kg) divided by height squared (m²). The outcome was evaluated among participants who completed the eight-week intervention and had available follow-up anthropometric measurements.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start29 Oct 2023
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight , ObesityStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The ACTION study comprised two sequential intervention cohorts with parallel exercise groups within each cohort. Initially, 113 participants were systematically allocated by enrolment order to structured jogging (n=77) or increased habitual physical activity (n=36). Following high intervention discontinuation, the protocol was modified for a new cohort of 85 participants. Exercise allocation was guided by the Genetic Endurance Score (GES): participants with high GES received jogging (n=35), whereas those with low GES received yoga (n=50). Each participant followed one assigned exercise strategy for eight weeks, alongside common dietary counselling. The genotype-guided strategy was developed after the initial intervention and was not prespecified at study inception.
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kalliopi G, National and Kapodistrian University of Athens
- Investigators
- Kalliopi K Gkouskou, PhD, Principal investigator, National and Kapodistrian University of Athens, School of MedicineAristides G Eliopoulos, PhD, Study chair, National and Kapodistrian University of Athens, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922005
- Sponsor's protocol ID
- ACTION-NKUA-001
- Acronym
- ACTION
- Status last verified
- Oct 2026
- First submitted
- 1 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data. The study includes genetic and health-related information. Any future data sharing would be subject to applicable data protection requirements, participant consent provisions, and approval by the responsible institution.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Interventions and Genetic Susceptibility in Body Mass Index Management: The ACTION Study
- ClinicalTrials.gov ID
- NCT07922005
- Acronym / sponsor ID
- ACTION / ACTION-NKUA-001
- Conditions
- Overweight , Obesity
- Keywords
- Polygenic Risk Score, Genetic Susceptibility to Obesity, Personalized Lifestyle Intervention, Body Mass Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 29 Oct 2023 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ACTION (Genotype-tAilored exerCise inTerventION) study investigated whether genetic information related to obesity susceptibility and endurance capacity could be used to inform personalized lifestyle interventions aimed at improving body mass index (BMI) and participation in physical activity programs.
Adults with increased genetic susceptibility to obesity and low habitual physical activity were invited to participate in an eight-week lifestyle intervention combining dietary counseling with physical activity recommendations.
The intervention initially compared structured jogging with recommendations to increase habitual physical activity. Following the evaluation of intervention completion, the exercise strategy was modified for a subsequent group of participants, incorporating a Genetic Endurance Score (GES) to guide allocation to jogging or yoga.
The study evaluated changes in BMI and completion of the assigned exercise programs, exploring the feasibility of integrating genetic information into personalized lifestyle recommendations.
Detailed description
The ACTION (Genotype-tAilored exerCise inTerventION) study was designed to investigate the potential of integrating polygenic susceptibility to obesity and genetically predicted endurance capacity into lifestyle interventions for BMI management.
The study included an observational analysis of 918 genotyped Greek adults recruited during two consecutive study periods. A weighted BMI Genetic Risk Score (BMI-GRS), based on 97 genetic variants, was used to assess obesity susceptibility, while habitual physical activity was assessed using the International Physical Activity Questionnaire (IPAQ-Gr).
Adults with increased obesity-related genetic susceptibility were invited to participate in the intervention component. Enrollment was prioritized for individuals with BMI-GRS values above the 70th percentile and low habitual physical activity. A total of 198 participants were enrolled in eight-week lifestyle interventions across two sequential cohorts.
All intervention participants received a common genetic risk-adapted dietary program and individualized lifestyle counseling. Dietary recommendations emphasized healthy eating habits, reduced saturated fat and refined carbohydrate intake, increased dietary fiber and plant-based food consumption, and regular fish consumption.
In the initial intervention cohort (n=113), participants were systematically allocated according to enrollment order to structured jogging (n=77) or recommendations to increase habitual physical activity (n=36). The primary objective was to evaluate changes in BMI following eight weeks of intervention.
Following discontinuation of the initial intervention, exploratory analyses investigated the association between genetically predicted endurance capacity and exercise program completion. These observations motivated a modification of the intervention strategy.
In the subsequent cohort (n=85), exercise allocation was guided by a nine-variant Genetic Endurance Score (GES). Participants with GES ≥50 were assigned to structured jogging (n=35), while those with GES <50 were assigned to structured yoga (n=50). This phase assessed eight-week intervention completion and short-term BMI change.
BMI was calculated from measured weight and height. Intervention completion was defined by completion of the assigned eight-week program and attendance at the final assessment. Discontinuation of the intervention was recorded.
Comparisons between the sequential intervention cohorts were considered exploratory because the cohorts were recruited at different times and exercise allocation procedures differed. The genotype-guided allocation strategy was developed following observations from the initial intervention and was not part of the original intervention design.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The ACTION study comprised two sequential intervention cohorts with parallel exercise groups within each cohort. Initially, 113 participants were systematically allocated by enrolment order to structured jogging (n=77) or increased habitual physical activity (n=36). Following high intervention discontinuation, the protocol was modified for a new cohort of 85 participants. Exercise allocation was guided by the Genetic Endurance Score (GES): participants with high GES received jogging (n=35), whereas those with low GES received yoga (n=50). Each participant followed one assigned exercise strategy for eight weeks, alongside common dietary counselling. The genotype-guided strategy was developed after the initial intervention and was not prespecified at study inception.
| Arm | Type | Receives |
|---|---|---|
| Structured Jogging | Experimental | Behavioral: Structured Jogging Program, Behavioral: Genetic Risk-Adapted Dietary CounselingParticipants assigned to structured jogging followed an eight-week exercise program together with common genetic risk-adapted dietary counseling. This arm included 77 participants from the initial cohort, allocated systematically by enrollment order, and 35 participants from the subsequent cohort, allocated according to a Genetic Endurance Score (GES) ≥50. A total of 112 participants received the jogging intervention. |
| Cohort-Specific Physical Activity | Active comparator | Behavioral: Habitual Physical Activity Recommendations, Behavioral: Structured Yoga Program, Behavioral: Genetic Risk-Adapted Dietary CounselingThis arm represents the alternative physical activity strategy used in each intervention cohort. In the initial cohort, 36 participants received recommendations to increase physical activity through their habitual activities. In the subsequent cohort, 50 participants with a Genetic Endurance Score (GES) <50 were assigned to structured yoga. Both groups received the common dietary counseling intervention for eight weeks. The two exercise strategies were implemented in separate, sequential cohorts and were not identical interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older.
- Greek residents who had previously undergone genome-wide genotyping and baseline anthropometric and lifestyle assessment.
- Elevated genetic susceptibility to obesity, defined by the High or Max BMI Genetic Risk Score (BMI-GRS) categories.
- Low habitual physical activity at baseline.
- Voluntary agreement to participate in an eight-week lifestyle intervention.
Key exclusion criteria (6 listed)
- Missing anthropometric measurements or essential baseline covariate data.
- Body-weight change greater than 3% during the preceding three months.
- Previous bariatric surgery.
- Untreated psychiatric disorders.
- Use of medications known to influence body weight.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Jogging ProgramAn eight-week structured jogging program aimed at increasing weekly physical activity relative to baseline. The intervention was implemented in both sequential cohorts: 77 participants in the initial cohort and 35 participants with a Genetic Endurance Score (GES) ≥50 in the subsequent cohort. All participants also received common dietary counseling. | Behavioural | Structured Jogging |
| Habitual Physical Activity RecommendationsParticipants received individualized recommendations to increase their weekly physical activity through their habitual forms of exercise, without assignment to a structured jogging or yoga program. This eight-week intervention was implemented in the initial cohort (n=36), alongside the common genetic risk-adapted dietary counseling program. Physical activity recommendations aimed to increase weekly activity relative to baseline. | Behavioural | Cohort-Specific Physical Activity |
| Structured Yoga ProgramAn eight-week structured yoga program assigned to participants with a Genetic Endurance Score (GES) below 50. The intervention was implemented in the subsequent cohort (n=50) as an alternative to structured jogging for individuals with lower genetically predicted endurance capacity. All participants also received the common genetic risk-adapted dietary counseling program. | Behavioural | Cohort-Specific Physical Activity |
| Genetic Risk-Adapted Dietary CounselingAll 198 intervention participants received a common eight-week genetic risk-adapted dietary counseling program designed to support gradual weight loss. Recommendations emphasized reducing saturated fat and refined carbohydrate intake, increasing dietary fiber and plant-based foods, regular fish consumption, and behavioral strategies to support dietary adherence. The same dietary protocol was applied in both sequential intervention cohorts. | Behavioural | Cohort-Specific Physical Activity, Structured Jogging |
Primary outcome
Percentage Reduction in Body Mass Index (BMI) From Baseline to Week 8
Time frame: Baseline and Week 8
Percentage BMI reduction was calculated as 100 × (baseline BMI - BMI at week 8) / baseline BMI, with positive values indicating a reduction in BMI. BMI was calculated from measured body weight (kg) divided by height squared (m²). The outcome was evaluated among participants who completed the eight-week intervention and had available follow-up anthropometric measurements.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data. The study includes genetic and health-related information. Any future data sharing would be subject to applicable data protection requirements, participant consent provisions, and approval by the responsible institution.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kalliopi K Gkouskou, PhD principal investigator
National and Kapodistrian University of Athens, School of Medicine
Aristides G Eliopoulos, PhD study chair
National and Kapodistrian University of Athens, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Jogging Program, Habitual Physical Activity Recommendations and Structured Yoga Program in people with Overweight , Obesity, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Reduction in Body Mass Index (BMI) From Baseline to Week 8 (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.